The following data is part of a premarket notification filed by Ray Co., Ltd with the FDA for Rayscan A-expert 3d.
| Device ID | K142247 |
| 510k Number | K142247 |
| Device Name: | RAYSCAN A-EXPERT 3D |
| Classification | X-ray, Tomography, Computed, Dental |
| Applicant | RAY CO., LTD 332-7, SAMSUNG1-RO Hwaseong-si, KR 445-330 |
| Contact | Kyungha Seo |
| Correspondent | Andew Paeng ANDEW PAENG 4747 HOEN AVE. Santa Rosa, CA 95405 |
| Product Code | OAS |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-07-29 |
| Decision Date | 2015-04-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800003000142 | K142247 | 000 |
| 08800003000135 | K142247 | 000 |
| 08800003000128 | K142247 | 000 |
| 08800003000111 | K142247 | 000 |
| 08800003000104 | K142247 | 000 |
| 08800003000098 | K142247 | 000 |
| 08800003000081 | K142247 | 000 |
| 08800003000074 | K142247 | 000 |
| 08800003000067 | K142247 | 000 |